The Wall Street Journal published an article today that the FBI is investigating laparoscopic power morcellators and their link to spreading cancer. Specifically, according to the article, the FBI is investigating what Johnson & Johnson knew about the complications and risks associated with the power morcellator
A power morcellator is a surgical tool used predominantly in laparoscopic surgeries for the division and removal of tissue and organs. It is estimated that approximately 650,000 women undergo hysterectomies and myomectomies a year in the United States for uterine fibroids.
Johnson & Johnson, is the largest manufacturer of the surgical tool. The device is sold by its Ethicon division.
In April 2014, the FDA issued a safety communication[1] advising against the use of power morcellators during laparoscopic procedures. J&J responded by suspending world-wide sales and distribution of its power morcellators.[2]
The FDA found that the risk of a woman undergoing a hysterectomy or myomectomy having an unsuspected sarcoma may be as high as 1 in 350 for all types of uterine sarcomas. This means many more women than originally suspected are at serious risk for spreading undetected cancer during what has been traditionally explained as a “routine” procedure.
In July 2014, the FDA convened an advisory panel to discuss mounting concern with the use of power morcellators in gynecological surgeries. The FDA panel issued a directive discouraging doctors from using the device because of the risk of spreading undetected cancer. Days later, J&J called for a voluntary worldwide market withdrawal of the tool.[3]
In November 2014, the FDA issued a black box warning – the highest level of caution – to help reduce the risk of spreading unsuspected uterine cancer in women being treated for uterine fibroids. The FDA recommended that manufacturers include warning that states in part: “The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”
Power morcellators should not be used on the vast majority of women because of these risks.
The FBI investigation – in addition to the complaints on file against the manufacturer – suggests J&J knew about the severe risk of these devices long before warning physicians and the public.
The WSJ article details specific instances where J&J was notified of concerns that the power morcellator could spread undetected cancer – including communication from a pathologist in 2006 specifically stating that the incidence of undetected cancer was higher than suggested by the company.[4] There have also been a number of studies showing that (1) laparoscopic power morcellators could disseminate tissue fragments and (2) the risk of having undetected sarcoma in women undergoing hysterectomies and myomectomies was higher than the 1 in 10,000 number touted by the manufacturers.
We will watch closely as the FBI investigation unfolds.
Women who suspect their cancer was spread during a morcellation hysterectomy may be eligible to file a morcellator cancer lawsuit to seek justice and compensation. Contact the medical device team at Anapol Schwartz to preserve your legal rights.
[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm
[2] http://www.wsj.com/articles/SB10001424052702304893404579531961812995326
[3] http://www.wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350
[4] http://m.bizjournals.com/pittsburgh/news/2014/05/30/j-j-alerted-in-2006-to-devices-surgical-risks.html?r=full
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